Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

July 6, 2010 updated by: Catalysis SL

Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

The purpose of the study is to determine whether Viusid administration improves malnutrition, atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects with Chronic Inflammatory Syndrome under hemodialysis treatment. The duration of this double-blind placebo controlled phase 3 clinical trial will be 60 weeks. All patients enrolled in the study will be receiving the standard treatment for Chronic Inflammatory Syndrome including hemodialysis and administration of a hypercaloric and hyperproteic diet. Efficacy assessment will be carried out 12 weeks after the end of Viusid or placebo treatment.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
      • Havana, Cuba, 10400
        • Institute of Nephrology "Dr. Abelardo Buch López"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with chronic terminal nephropathy under hemodialysis treatment for at least 3 months
  • Signed informed consent

Exclusion Criteria:

  • Patients with chronic terminal nephropathy previously treated with peritoneal dialysis
  • Receptors of a renal graft
  • Patients with malignant neoplastic conditions
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
Dietary supplement: Viusid
3 Viusid bags (Orally administered) per day, for 60 weeks
Placebo Comparator: B
Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
Dietary supplement: Placebo
3 Placebo bags (Orally administered) per day, for 60 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body mass index (BMI) at week 72 (end of the treatment)
Time Frame: 72 weeks
72 weeks
Carotidal Doppler at week 72 (end of the treatment)
Time Frame: 72 weeks
72 weeks
C reactive protein at weeks 72 (end of the treatment)
Time Frame: 72 weeks
72 weeks
Hemoglobin at week 72 (end of the treatment)
Time Frame: 72 weeks
72 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cholesterol at week 72
Time Frame: 72 weeks
72 weeks
Triglycerides at week 72
Time Frame: 72 weeks
72 weeks
Frequency of infection episodes at week 72
Time Frame: 72 weeks
72 weeks
Creatinine at week 72
Time Frame: 72 weeks
72 weeks
Uric acid at week 72
Time Frame: 72 weeks
72 weeks
Glutamic-pyruvic transaminase (GPT)at week 72
Time Frame: 72 weeks
72 weeks
Glutamic-oxaloacetic transaminase (GOT)at week 72
Time Frame: 72 weeks
72 weeks
Blood glucose concentrations at week 72
Time Frame: 72 weeks
72 weeks
Gasometry at week 72
Time Frame: 72 weeks
72 weeks
Adverse effects at week 72
Time Frame: 72 weeks
72 weeks
Albumin at week 72
Time Frame: 72 weeks
72 weeks
KTV at week 72
Time Frame: 72 weeks
72 weeks
Phosphocalcic metabolism at week 72
Time Frame: 72 weeks
72 weeks
Hematocrit at week 72
Time Frame: 72 weeks
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Mirna Atiés Sánchez, MD, Institute of Nephrology "Dr. Abelardo Buch López"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 15, 2009

First Posted (Estimate)

September 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0907-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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